A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

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This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C will be conducted in healthy subjects. Parts D, E, and F will be conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: from baseline through safety follow-up (up to 10 days after last dose for Part A, B, and C) ]

Number of subjects with AEs and SAEs will be reported.

Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: from baseline through safety follow-up (up to 35 days after last dose for Parts D, E, and F). ]

The absolute change in CFQ-R respiratory domain score will be reported.

Maximum observed concentration (Cmax) of VX-445,TEZ and metabolites (M1-TEZ and M2-TEZ), IVA and metabolites (M1-IVA and M6-IVA) and VX-561 [ Time Frame: from Day 1 through Day 43 ]

Maximum plasma concentration [Cmax] will be reported.

Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-445, TEZ and metabolites (M1-TEZ and M2-TEZ), IVA and metabolites (M1-IVA and M6-IVA) and VX-561 [ Time Frame: from Day 1 through Day 43 ]

Area under the concentration versus time curve during a dosing interval (AUCtau) will be reported.

Observed pre-dose concentration (Ctrough) of VX-445, TEZ and metabolites (M1-TEZ and M2-TEZ), IVA and metabolites (M1-IVA and M6-IVA) and VX-561 [ Time Frame: from Day 1 through Day 43 ]

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